Blog

The trend in infectious disease diagnostics has reversed

written by Aleksi Soini

posted on November 21, 2025

The 2010s were a golden decade for the development of new diagnostic technologies. New start-ups sprang up in infection diagnostics like mushrooms after the rain. Venture capital was available even for the weakest technological solutions, as far as the company flagged the magic letters “PCR”. The market trend favoured solutions based on the amplification of nucleic acids. This was fuelled by hype, not by research evidence. PCR was applied indiscriminately to all possible applications of infection diagnostics, without consideration as to whether the technology was suitable for the specific purpose.

The turning point

Now the trend has changed. Leading infectious disease specialists and laboratories are finally recognizing that antigen testing is the most accurate and effective method for detecting acute infections and identifying infectious patients.

The right method for the right disease

In the 2010s, hundreds of new IVD test products based on gene amplification were launched. The marketing budgets for these new products were impressive. As a result of aggressive marketing and peer pressure, laboratories rushed to adopt these ultrasensitive tests without investigating their true clinical performance. Detecting fragments of RNA or DNA in a clinical sample was equated with an acute infection, even though basic microbiology tells us otherwise. The presence of genetic material alone does not prove the existence of a live, infectious pathogen – just think about Koch’s postulates. Few laboratory professionals sought research evidence on the clinical accuracy of the new PCR methods. Still, and without research evidence, most laboratory medicine professionals were ready to give PCR tests the “gold standard” status.

Lessons learned during the pandemic

The research evidence gathered during the COVID-19 pandemic shows clearly that methods based on identifying the phenotype of a pathogen – such as antigen tests – are far more accurate than gene amplification methods in differential diagnosis of acute infections and in identifying contagious individuals. In fact, the research has unequivocally shown that PCR is not suitable for assessing infectivity. Instead, PCR is a valuable tool for other applications, such as for ruling out a pathogen or a disease.

Many doctors experienced firsthand the challenges of PCR testing while treating patients during the pandemic. They saw PCR results remain positive long after the patient had recovered and long after they knew that the patient was no longer contagious. This led to unnecessary isolation measures in hospitals, which become expensive. These experiences revealed a mismatch between laboratory testing practices and the clinical needs.

The end of the “wild years”

ArcDia launched the mariPOC® product family for automated testing of acute infections in 2010, based on phenotypic methodology. It was no coincidence that we chose a phenotypic methodology as the basis for the mariPOC® product line. Already in the 2000s, research evidence and theory supported the accuracy of antigen testing in identifying acute infections.

In the following years, hundreds of competitors tried to outperform mariPOC® using gene amplification technologies. Yet, as ArcDia predicted, antigen-based methods have ultimately prevailed in the rapid testing market for respiratory infections. Since the pandemic, many PCR-based product lines have been withdrawn either for financial or technical reasons. Despite billions invested, most of these companies never yielded profitable business. The market adoption of POC-PCR and alike methods has remained low (Johnson 2025). After fierce market competition, only a few PCR product lines managed to establish their position in the IVD market.

The market has matured — and mariPOC® leads the way

As we expected, the PCR hype proved to be a bubble. The “wild years” of infectious disease diagnostics are over. Most forward-looking clinicians now rely on automated antigen testing — a solution that provides fast, accurate, and clinically meaningful diagnostics. Today in 2025, mariPOC is replacing PCR devices in the POC market. mariPOC® continues to set the standard for evidence-based, cost-efficient and scalable diagnostics that meet both medical and operational needs in modern healthcare.

Aleksi Soini, PhD, Adjunct professor in bioanalytics
Founder, ArcDia International Ltd

VIITTEET:

Robert Koch. (n.d.). In Wikipedia. Retrieved November 8, 2025, from https://fi.wikipedia.org/wiki/Robert_Koch

Johnson, M. (2025, July 29). Where’s the demand? A decade after first CLIA waiver, molecular POC testing adoption remains slow. 360Dx. Retrieved November 8, 2025, from https://www.360dx.com/point-care-testing/wheres-demand-decade-after-first-clia-waiver-molecular-poc-testing-adoption